[Pharmwaste] FW: Sample prescription drugs

Tue Oct 14 21:19:37 EDT 2008

Good catch, Jeff!  I don't think hazardous waste status is a factor in
sampling since it is primary a marketing tool. We do have clients who
refuse to take samples that become hazardous waste. 

Best regards,

Charlotte A. Smith, R. Ph., M.S., HEM

President

PharmEcology Associates, LLC

12229 W. North Ave., Suite 2

Wauwatosa, WI 53226

414-292-3959

414-915-4026 (cell)

csmith at pharmecology.com

www.pharmecology.com

________________________________

From: Jeff Hollar [mailto:jhollar at pwaste.com] 
Sent: Tuesday, October 14, 2008 8:20 PM
To: Charlotte A. Smith; 'Tenace, Laurie';
pharmwaste at lists.dep.state.fl.us
Cc: ayoungblut at cvmspc.com
Subject: RE: [Pharmwaste] FW: Sample prescription drugs

Laura, Charlotte, All,

One would think that a manufacturer would not distribute samples of a
product that is considered a RCRA hazardous waste when discarded, but it
does happen.  Example: Jantoven (Warfarin Sodium), EPA Waste Code =
P001.

Jeff Hollar

President

PharmWaste Technologies, Inc.

4164 NW Urbandale Dr., Suite A

Urbandale, IA 50322

(P) 515-276-5302 Ext. 316

(F) 480-393-5564

(E) Jhollar at Pwaste.com

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From: Charlotte A. Smith [mailto:csmith at pharmecology.com] 
Sent: Tuesday, October 14, 2008 7:35 PM
To: Tenace, Laurie; pharmwaste at lists.dep.state.fl.us
Cc: ayoungblut at cvmspc.com
Subject: RE: [Pharmwaste] FW: Sample prescription drugs

I'm not sure about the Florida statute, but the FDA Prescription Drug
Marketing Act prohibits manufacturers' representatives from picking up
samples once they have been distributed. I believe the rep can assist
the clinic in packaging them up for return to the manufacturer, but
realistically, that doesn't happen. It's important to remember that any
clinic that generates pharmaceutical waste of any type has the
responsibility of determining if the waste drugs are RCRA hazardous
waste. While most samples would not be listed drugs, since it is newer
drugs that are sampled and the regulations have not been updated, it is
possible that the samples could exhibit one of the characteristics of
hazardous waste. It is not therefore appropriate for businesses to use
the landfill option without reviewing their drugs first. It is also not
a best management practice. Clinics should check with their regulated
medical waste vendors and see if disposal of non-hazardous
pharmaceutical waste by incineration is an option for them. If they do
have RCRA hazardous waste, they will need a hazardous waste vendor also.

I hope this helps. 

Best regards,

Charlotte A. Smith, R. Ph., M.S., HEM

President

PharmEcology Associates, LLC

12229 W. North Ave., Suite 2

Wauwatosa, WI 53226

414-292-3959

414-915-4026 (cell)

csmith at pharmecology.com

www.pharmecology.com

________________________________

From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Tenace,
Laurie
Sent: Tuesday, October 14, 2008 1:52 PM
To: pharmwaste at lists.dep.state.fl.us
Cc: ayoungblut at cvmspc.com
Subject: [Pharmwaste] FW: Sample prescription drugs

Can anyone help this person?

This question comes up a lot for me. A Florida Statute says, "All
out-of-date drug samples must be returned to the manufacturer or
distributor of that drug sample." (Ch. 499.028(9), F.S.) However every
drug rep I've asked (just while waiting to see doctors at various times)
has never heard this and insists that they do not take back samples. 

Thanks!

Laurie

Laurie J. Tenace
Environmental Specialist
Florida Department of Environmental Protection
2600 Blair Stone Road, MS 4555
Tallahassee, Florida 32399-2400
PH: (850) 245-8759
FAX: (850) 245-8811
Laurie.Tenace at dep.state.fl.us 

Mercury web pages:
http://www.dep.state.fl.us/waste/categories/mercury/default.htm

Unwanted Medications web pages:
http://www.dep.state.fl.us/waste/categories/medications/default.htm

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From: Angie Youngblut [mailto:AYoungblut at cvmspc.com] 
Sent: Tuesday, October 14, 2008 2:39 PM
To: pharmwaste at lists.dep.state.fl.us
Subject: FW: Sample prescription drugs

I have been trying to get one clear answer- and haven't had much
success. I have tried EPA, DNR, Iowa Board of Pharmacy, local landfill
and others. I have expired sample prescription drugs to dispose of and I
don't want to break any regulations, however I have been told I am a
"waste generating facility" and therefore have different rules. It has
been recommended to me to mix them with undesirable substances and put
in regular trash and that they are not considered hazardous.

I do not have the option of giving them to a charitable organization
because they will only take them( in the Iowa Drug Repository program)
with a year left on the expiration and our offices keep them until they
expire. 

Is there any clear guideline federally or in Iowa that I have missed? 

Angie Youngblut RN, BS 
Clinical Practice Manager 
Cedar Valley Medical Specialists, P.C. 
4150 Kimball Avenue 
Waterloo, Iowa 50701 
Phone 319-235-5390 
Fax 319-287-9249 
ayoungblut at cvmspc.com 

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